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NCT Number: NCT07777666

Effects of Kefir on Celiac Disease

This study will investigate whether regular consumption of kefir can reduce gastrointestinal symptoms and improve quality of life in adults with celiac disease who follow a strict gluten-free diet. The study will use a randomized cross-over design in which participants will consume kefir during one study period and continue their usual diet without kefir during another period.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maribor, Faculty of Health Sciences

Maribor, 2000, Slovenia

Location contact

SABINA FIJAN, PhD

CONTACT

[email protected]

+38623004755

About this study

Celiac disease is a chronic autoimmune disease triggered by gluten consumption. Although a strict gluten-free diet is the only established treatment, some individuals continue to experience gastrointestinal symptoms and reduced quality of life.

The CeliKef study will investigate whether regular consumption of kefir may help alleviate gastrointestinal symptoms and improve quality of life in adults with celiac disease following a strict gluten-free diet. The study will include approximately 30 participants and will use a randomized cross-over design. Each participant will undergo a kefir consumption period and a period without kefir, separated by a washout period. Gastrointestinal symptoms and celiac disease-related quality of life will be assessed during the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older with a confirmed diagnosis of celiac disease.
  • Following a strict gluten-free diet.

Exclusion criteria

  • Other chronic gastrointestinal diseases.
  • Pregnancy.
  • Known allergy or intolerance to milk or dairy products or other components of kefir.

Treatment and study plan

Kefir

Dietary Supplement

Participants will consume 200 mL kefir prepared from starter cultures daily for 4 weeks. The kefir will be provided for the intervention period.

Primary outcomes

  1. Change in gastrointestinal symptoms assessed by the Gastrointestinal Symptom Rating Scale (GSRS)

    Time frame: Baseline, after each 4-week intervention period, and after the 4-week washout period

    Change in GSRS score between the kefir consumption period and the period without kefir. The GSRS is a validated questionnaire assessing gastrointestinal symptoms.

Secondary outcomes

  1. Celiac disease-related quality of life assessed by the Celiac Disease Quality of Life questionnaire (CD-QOL)

    Time frame: Baseline, after each 4-week intervention period, and after the 4-week washout period

    Change in CD-QOL score between the kefir consumption period and the period without kefir.

  2. Stool consistency assessed by the Bristol Stool Form Scale (BSFS)

    Time frame: Baseline, after each 4-week intervention period, and after the 4-week washout period

    Change in stool consistency assessed using the Bristol Stool Form Scale during the kefir consumption period compared with the period without kefir.

    Time Frame

  3. Adherence to a gluten-free diet assessed by the Celiac Dietary Adherence Test (CDAT)

    Time frame: Baseline, after each 4-week intervention period, and after the 4-week washout period

    Change in CDAT score between the kefir consumption period and the period without kefir.

Study contacts

Contact information is provided by the study sponsor or research team.

SABINA FIJAN, PhD

CONTACT

[email protected]

+38623004755

Sponsors and collaborators

Lead sponsor

University Maribor

Other

Registry information

Official study title

Effects of Kefir Consumption on Celiac Disease Symptoms

Acronym: CeliKef

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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